ROi CPS Recalls Labor and Delivery Kits Due to Labeling Error
ROi CPS LLC is recalling 220 labor and delivery kits because of an incorrect expiration date on the label.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (incorrect expiration date) without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ROi CPS LLC is recalling 220 labor and delivery kits, which are obstetric gynecologic specialized manual instruments. The recall is being conducted due to a labeling error involving an incorrect expiration date.
The affected products were distributed nationwide in the United States, specifically in the states of Missouri and Oklahoma. The recall covers kits with lot numbers 78483C, 79932C, 81043C, 82586C, and 83090C.
Consumers and healthcare facilities should check their inventory for these specific lot numbers. If the products are found, they should be removed from use and returned to the distributor or manufacturer according to the recall instructions.
The recalled product
- Product
- Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 220
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Numbers: 78483C
- 79932C
- 81043C
- 82586C
- 83090C.
Distribution
Related recalls
Same manufacturer · ROi CPS LLC
See all →- SevereNewborn Resuscitator Kit Recalled for Inline Spring Defect
FDA (Devices) · 2025-02-12
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighRegard Kit Decanters Recalled for Defective Sterile Packaging
FDA (Devices) · 2024-08-28
- CriticalSurgical Convenience Kit Recalled Due to Defective Component
FDA (Devices) · 2024-01-24
- SevereRegard Dressing Change Kit Recalled Due to Defective Irrigation Solution
FDA (Devices) · 2024-01-10
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
Similar recalls
- ModerateROi CPS LLC Recalls Respirator Crash Cart Kits Due to Labeling Error
FDA (Devices) · 2020-07-08
- ModerateROi CPS Recalls Isolation Droplet Bundle Kits Due to Labeling Error
FDA (Devices) · 2020-07-08
- HighNonsterile convenience kit recall due to sterile component mislabeling
FDA (Devices) · 2022-07-27
- ModerateIV Start Kit convenience kits recalled for manufacturing validation defect
FDA (Devices) · 2022-05-04
- HighIV Start Kit Convenience Kits Recalled for Inadequate Test Method Validation
FDA (Devices) · 2022-05-04
- ModerateIV Start Kit Convenience Kits Recalled for Manufacturing Test Validation Issue
FDA (Devices) · 2022-05-04